Xalkori

Xalkori Manufacturers

• Pfizer Laboratories Div Pfizer Inc
  

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  Xalkori | Pfizer Laboratories Div Pfizer Inc

  

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  2.1 Patient Selection

  Select patients for the treatment of metastatic NSCLC with XALKORI based on the presence of ALK positivity in tumor specimens [see Indications and Usage (1) and Clinical Studies (14)]. Information on FDA-approved tests for the detection of ALK rearrangements in NSCLC is available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm.

  2.2 Recommended Dosing

  The recommended dose of XALKORI is 250 mg orally, twice daily until disease progression or no longer tolerated by the patient. The recommended dose of XALKORI in patients with severe renal impairment (creatinine clearance <30 mL/min) not requiring dialysis is 250 mg orally, once daily [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  XALKORI may be taken with or without food. Swallow capsules whole. If a dose of XALKORI is missed, make up that dose unless the next dose is due within 6 hours. If vomiting occurs after taking a dose of XALKORI, take the next dose at the regular time.

  2.3 Dose Modification

  Reduce dose as below, if one or more dose reductions are necessary due to adverse reactions of Grade 3 or 4 severity, as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0:

  First dose reduction: XALKORI 200 mg taken orally twice daily Second dose reduction: XALKORI 250 mg taken orally once daily Permanently discontinue if unable to tolerate XALKORI 250 mg taken once daily

  Dose reduction guidelines are provided in Tables 1 and 2.

  Table 1. XALKORI Dose Modification – Hematologic Toxicities* CTCAE Grade XALKORI Dosing * Except lymphopenia (unless associated with clinical events, e.g., opportunistic infections). Grade 3 Withhold until recovery to Grade 2 or less, then resume at the same dose schedule Grade 4 Withhold until recovery to Grade 2 or less, then resume at next lower dose Table 2. XALKORI Dose Modification – Non-Hematologic Toxicities Criteria XALKORI Dosing * Heart rate less than 60 beats per minute (bpm). † Permanently discontinue for recurrence. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation greater than 5 times upper limit of normal (ULN) with total bilirubin less than or equal to 1.5 times ULN Withhold until recovery to baseline or less than or equal to 3 times ULN, then resume at reduced dose ALT or AST elevation greater than 3 times ULN with concurrent total bilirubin elevation greater than 1.5 times ULN (in the absence of cholestasis or hemolysis) Permanently discontinue Any Grade drug-related interstitial lung disease/pneumonitis Permanently discontinue QTc greater than 500 ms on at least 2 separate ECGs Withhold until recovery to baseline or to a QTc less than 481 ms, then resume at reduced dose QTc greater than 500 ms or greater than or equal to 60 ms change from baseline with Torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia Permanently discontinue Bradycardia* (symptomatic, may be severe and medically significant, medical intervention indicated) Withhold until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above
  
  Evaluate concomitant medications known to cause bradycardia, as well as anti-hypertensive medications
  
  If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume at previous dose upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above
  
  If no contributing concomitant medication is identified, or if contributing concomitant medications are not discontinued or dose modified, resume at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above Bradycardia*,† (life-threatening consequences, urgent intervention indicated) Permanently discontinue if no contributing concomitant medication is identified
  
  If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume at 250 mg once daily upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, with frequent monitoring Visual Loss (Grade 4 Ocular Disorder) Discontinue during evaluation of severe vision loss

  Monitor complete blood counts including differential white blood cell counts monthly and as clinically indicated, with more frequent repeat testing if Grade 3 or 4 abnormalities are observed, or if fever or infection occurs.

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